Danish MedTech company, °MEQU announces 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) of the °M Warmer System - a ...
Eisai Co., and Biogen announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Applicat...
The test uses highly sensitive PCR technology, requiring only a single nasal-swab sample to provide rapid, accurate qualitative detection and different...
Moderna's Investigational Therapeutic for Methylmalonic Acidemia (mRNA-3705) Selected by U.S. Food & Drug Administration for START Pilot Program ...
Bio-Thera Solutions , a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, announced th...
START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate the development of novel drug and biological p...
ASP Japan LLC (hereinafter referred to as ASP Japan) was announced by HOYA Group PENTAX Europe GmbH ( hereinafter referred to as PENTAX Medical) and the ...
These enhancements represent Thermo Fisher's steadfast commitment to ensuring the highest standards of safety and efficacy in cytogenetic t...
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo®(nivolumab) in combination with cisplatin and gemcitabine ...
– Priority Review recognizes the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options...
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma FDA Priority Review gran...
Wyost® (denosumab) and Jubbonti® (denosumab) approved by EC for all indications of denosumab reference medicines Xgeva® and Prolia® EC a...
Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial inf...
The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with pa...
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